UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058080 |
|---|---|
| Receipt number | R000066368 |
| Scientific Title | Sleep literacy education and empowerment program for uplifting pupils (SLEEP-UP): A multilevel, school- and municipality-based intervention to promote children and adolescents' sleep health |
| Date of disclosure of the study information | 2025/06/04 |
| Last modified on | 2025/06/04 15:04:49 |
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Basic information
Public title
A project to promote children and adolescents' sleep health through a community- and school-based sleep education program
Acronym
SLEEP-UP project
Scientific Title
Sleep literacy education and empowerment program for uplifting pupils (SLEEP-UP): A multilevel, school- and municipality-based intervention to promote children and adolescents' sleep health
Scientific Title:Acronym
SLEEP-UP (Sleep Literacy Education and Empowerment Program for Uplifting Pupils) study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will implement a year-long, multilevel sleep education model in Ohda City, Shimane Prefecture, through collaboration among schools, families, the local community, government, and businesses, and will evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change in the proportion of students who meet the recommended sleep duration according to the 2023 Japanese Sleep Guidelines for Health Promotion (i.e., 9 hours or more per night for elementary school children and 8 hours or more per night for junior high school students) on weekdays, assessed at baseline (pre-intervention) and at the end of the intervention (12 months post-intervention), and compared between the intervention and control groups.
Key secondary outcomes
1) Proportion of students whose bedtime is advanced by at least 15 minutes from baseline
2) Proportion of students whose total weekday sleep duration increases by at least 105 minutes per week from baseline
3) Proportion of students whose difference in sleep timing between weekdays and weekends (social jetlag, SJL) is within 60 minutes
4) Changes in subjective fatigue, assessed using a short fatigue scale validated for Japanese elementary and junior high school students (the scale name is not specified; the items used and reference will be disclosed in the study protocol)
5) Changes in daytime sleepiness, assessed using the Pediatric Daytime Sleepiness Scale (PDSS), including both changes in total scores and the proportion of students above or below the cutoff value
6) Changes in subjective mental well-being, assessed using the WHO-5 Well-Being Index, including both changes in total scores and the proportion of students above or below the cutoff value
7) Changes in sleep-related behaviors, assessed using a behavior change stage model developed for this study based on previous research frameworks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention group
A 12-month, multilevel sleep education program will be implemented for elementary and junior high school students (grades 4-9), their parents/guardians, school staff, and community members in Ohda City, Shimane Prefecture. This comprehensive intervention, based on the framework of community-wide campaigns (CWC), involves collaboration among schools, families, the local community, government, and businesses.
Key components include:
School-based sleep education through classes, lectures, and workshops
Information provision and events for parents/guardians
Community events (e.g., awareness booths at shopping malls, information in community newsletters)
Scientific monitoring of sleep habits using actigraphy and sleep diaries, with individualized feedback every two weeks
Distribution of visual behavioral prompts (e.g., rulers, underlays with slogans)
Tailored support based on participants' stages of behavioral change (behavior change stage model)
Use of social marketing strategies (4Ps: Product, Price, Place, Promotion) for information dissemination
Duration and frequency:
12-month intervention (June 2025-May 2026)
Actigraphy and sleep diary monitoring by parent-child pairs for specified periods, with feedback every two weeks
Multiple educational sessions and events at schools and in the community
Ongoing provision of information via school and community newsletters
Note:
The program is designed to optimize support and information provision according to each participant's stage of behavioral change, integrating individual, family, school, and community levels to promote sustainable improvements in sleep behaviors.
Interventions/Control_2
Control Group
Description:
The control group will receive a standard, school-based sleep education program administered once during the school term. This program, delivered during regular class hours, is designed to provide students with accurate knowledge about sleep, encourage self-assessment of sleep habits and daily routines, and promote the setting and practice of achievable behavioral goals. The main components are as follows:
Main components:
Sleep health education (approximately 40 minutes) using PowerPoint and quiz-based materials
Explanation of the importance of sleep, strategies for improving sleep, and relevant lifestyle habits
Implementation of a 12-item checklist for sleep-promoting behaviors, along with self-assessment of current habits
Selection of 2-3 attainable behavioral goals from the checklist, with encouragement for students to practice these goals in their daily lives
Students are instructed to implement the selected goals for approximately two weeks
Questionnaire assessments are conducted at the same time points and frequency as in the intervention group
Duration and frequency:
Observation period: 12 months (June 2025 to May 2026)
Sleep education program: Once during the term (approximately 60 minutes)
Behavioral goal implementation period: Approximately two weeks (recommended)
Questionnaire surveys: Conducted at baseline, interim, and post-intervention, following the same schedule as the intervention group
Notes:
The content of the intervention follows the conventional sleep education program and does not include any multilayered or community-wide components.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 9 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Boys and girls enrolled in grades 4 through 9 (elementary grade 4 to junior high grade 3)
2) Children and students attending public elementary or junior high schools in the city
Key exclusion criteria
1) Children and students enrolled in special needs schools
2) Schools or classes where consent for participation could not be obtained
3) Schools or classes deemed unsuitable for study implementation
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Norihisa |
| Middle name | |
| Last name | Tamura |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
7398524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima city, Hiroshima, Japan
TEL
0824246803
tamura65@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihisa |
| Middle name | |
| Last name | Tamura |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
7398524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima city, Hiroshima, Japan
TEL
0824246803
Homepage URL
tamura65@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology/Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Review Board, Graduate School of Humanities and Social Sciences, Hiroshima University
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima, 739-8524 JAPAN
Tel
+81-82-424-6705
ed-ken-zai@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066368
